Esophageal Cancer Clinical Trial
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Summary
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Eligibility Criteria
Key Inclusion Criteria:
Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
ECOG PS ≤ 1 within 7 days prior to randomization
Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization
Key Exclusion Criteria:
Has squamous cell or undifferentiated or other histological type GC
Active leptomeningeal disease or uncontrolled brain metastasis
Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
Prior therapy with an anti-PD-1, anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 128 Locations for this study
Sacramento California, 95817, United States
Newnan Georgia, 30265, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
West Reading Pennsylvania, 19611, United States
Nashville Tennessee, 37203, United States
Bengbu Anhui, 23300, China
Hefei Anhui, 23008, China
Hefei Anhui, 23120, China
Beijing Beijing, 10002, China
Beijing Beijing, 10002, China
Beijing Beijing, 10003, China
Beijing Beijing, 10005, China
Beijing Beijing, 10008, China
Beijing Beijing, 10014, China
Beijing Beijing, 10085, China
Beijing Beijing, 10110, China
Fuzhou Fujian, 35000, China
Fuzhou Fujian, 35001, China
Lanzhou Gansu, 73000, China
Foshan Guangdong, 52800, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51008, China
Shenzhen Guangdong, 51802, China
Guilin Guangxi, 41000, China
Haikou Hainan, 57031, China
Shijiazhuang Hebei, 50051, China
Harbin Heilongjiang, 15008, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45005, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41000, China
Changsha Hunan, 41000, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21002, China
Nantong Jiangsu, 22636, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13000, China
Shenyang Liaoning, 11000, China
Shenyang Liaoning, 11001, China
Shenyang Liaoning, 11004, China
Jinan Shandong, 25011, China
Linyi Shandong, 27600, China
Qingdao Shandong, 26607, China
Shanghai Shanghai, 20002, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20008, China
Shanghai Shanghai, 20009, China
Chongqing Sichuan, 40004, China
Tianjin Tianjin, 30005, China
Tianjin Tianjin, 30006, China
Kunming Yunnan, 65011, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Nice cedex 02 Alpes Maritimes, 06189, France
Dijon cedex Côte-d'Or, 21079, France
Pessac Gironde, 33604, France
Besançon , , France
Marseille , , France
Montbéliard , , France
Torrette Ancona, 60020, Italy
San Giovanni Rotondo Foggia, 71013, Italy
Bologna , 40138, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pisa , 56126, Italy
Roma , 133, Italy
Torino , 10126, Italy
Chiba-shi Chiba-Ken, 260-8, Japan
Kamogawa-shi Chiba-ken, 296-8, Japan
Fukui-shi Fukui-ken, 910-8, Japan
Fukuoka-shi Fukuoka-Ken, 811-1, Japan
Ota-shi Gunma -ken, 373-8, Japan
Takasaki-shi Gunma-ken, 370-0, Japan
Hiroshima-shi Hiroshima-ken,, 730-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Amagasaki-shi Hyogo-ken, 660-8, Japan
Kanazawa-shi Ishikawa-ken, 920-8, Japan
Kita-gun Kagawa-Ken, 761-0, Japan
Yokohama Kanagawa, 241-8, Japan
Yufu-shi Oita-Ken, 879-5, Japan
Kurashiki-shi Okayama-ken, 710-8, Japan
Okayama-shi Okayama-ken, 700-8, Japan
Izumi-shi Osaka-Fu, 594-0, Japan
Osaka-shi Osaka-fu, 540-0, Japan
Suita Osaka, 537-8, Japan
Suita Osaka, 565-0, Japan
Hidaka-shi, Saitama-ken, 350-1, Japan
Ina Saitama, , Japan
Hamamatsu-shi Shizuoka-Ken, 431-3, Japan
Osaka-fu Takatsuki-shi, 569-8, Japan
Chuo-ku Tokyo-To, 104-0, Japan
Fuchu-shi Tokyo-to, 183-8, Japan
Koto-ku Tokyo-To, 135-8, Japan
Shinjuku-ku Tokyo-To, 162-8, Japan
Kurashiki , 710-8, Japan
Osaka , 989-6, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Seoul Gyeonggi-do, 03722, Korea, Republic of
Suwon-si Gyeonggi-do, 16247, Korea, Republic of
Suwon Gyeonggi-do, 16499, Korea, Republic of
Daegu Gyeongsangbuk-do, 41404, Korea, Republic of
Hwasun Jeollanam-do, , Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06973, Korea, Republic of
Seoul , 3080, Korea, Republic of
Seoul , 5505, Korea, Republic of
Gdansk , 80-95, Poland
Lodz , 90-24, Poland
Poznan , 60-69, Poland
Warszawa , 02-03, Poland
San Juan , 902, Puerto Rico
Ivanovo , 15304, Russian Federation
Moscow , 12951, Russian Federation
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
Omsk , 64401, Russian Federation
Pesochnyy , 19775, Russian Federation
Saint Petersburg , , Russian Federation
Samara , 44301, Russian Federation
Volgograd , , Russian Federation
Yaroslavl , 15005, Russian Federation
Barcelona , 8036, Spain
Bilbao , , Spain
Elche , , Spain
Madrid , 28007, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Majadahonda , , Spain
Málaga , 29010, Spain
Pamplona , , Spain
Sevilla , 41013, Spain
Valence , , Spain
Valencia , , Spain
Zaragoza , 50009, Spain
Kaohsiung , 807, Taiwan
Tainan , 704, Taiwan
Taipei , 11217, Taiwan
Adana , 1130, Turkey
Ankara , 6105, Turkey
Antalya , 7058, Turkey
Malatya , 44280, Turkey
Cardiff , , United Kingdom
London , , United Kingdom
How clear is this clinincal trial information?